CeNeRx BioPharma Initiates Phase II Clinical Trial Of Its Novel Antidepressant Agent Tyrima(TM)

CeNeRx BioPharma,
Inc., a clinical stage company developing and commercializing innovative
treatments for diseases of the central nervous system, announced that
it has initiated a Phase II clinical trial for its lead product candidate
Tyrima(TM) for the treatment of major depressive disorder (MDD). Tyrima is
a selective and reversible member of a novel class of drugs known as RIMAs,
or reversible inhibitors of monoamine oxidase A (MAO-A). The primary
objective of this Phase II trial is to evaluate the antidepressant efficacy
of Tyrima in patients with confirmed MDD. The trial design incorporates a
number of features intended to reduce the variability and placebo response
often observed in MDD clinical trials.



The randomized, double-blind, placebo-controlled Phase II trial will
enroll approximately 272 patients with moderate to severe MDD who will
receive either Tyrima or placebo for six weeks. The primary study objective
of antidepressant efficacy will be assessed using the Montgomery-Asberg
Depression Rating Scale (MADRS). Secondary objectives of the study include
evaluation of safety, tolerability, and pharmacokinetics of Tyrima. The
trial design was supported by a Tyrima Phase I safety database of 106
subjects and a PET (positron emission tomography) study that yielded
critical insight into the dose-response relationship of Tyrima. A number of
patients are already randomized in the trial and initial results are
expected by the end of 2009.



"Tyrima has the potential to be the first triple-action antidepressant
with a safety profile appropriate for the treatment of a broad population
of patients with depression, and we are committed to generating robust
clinical data from this Phase Il trial," said Dr. Daniel Burch, Executive
Vice President of R&D and Chief Medical Officer of CeNeRx. "We worked
closely with experienced MDD clinical trial experts, disease specialists,
and biostatisticians to incorporate a number of features in the study
design intended to manage the issues that can confound antidepressant
clinical trial results."



Depression clinical trial expert Dr. Norman Rosenthal, Medical Director
of Capital Clinical Associates and one of the lead investigators of the
Tyrima Phase II study noted, "The CeNeRx team gets high marks for designing
a first-class clinical trial. Recent efforts to test new antidepressants
have encountered technical difficulties, such as a high placebo effect,
which the current trial works hard to avoid. I am optimistic that the
present trial should enable us to assess the potential of Tyrima as a
potentially valuable new antidepressant agent."



Similar to the mechanism of conventional monoamine oxidase A inhibitors
(MAOI), the triple-action mechanism of Tyrima elevates the levels of three
key neurotransmitters (serotonin, norepinephrine and dopamine) that
positively affect mood and anxiety, compared to the one or two
neurotransmitters addressed by most current antidepressant drugs. This
triple-action mechanism has the potential to provide improved
antidepressant efficacy in some patients, while the selectivity and
reversibility of Tyrima are expected to reduce or eliminate the risk of
food-associated cardiovascular side effects of conventional MAOIs.
















"A substantial subset of patients suffering from depression responds
much better to treatment with MAOIs than other therapies, yet the risk of
food-associated cardiovascular side effects of conventional MAOIs have
greatly restricted their use, to the disadvantage of our patients," said
Dr. Alexander Bodkin, a Tyrima Phase II investigator and Director of the
Clinical Psychopharmacology Research Program at McLean Hospital of Harvard
Medical School. "A novel agent such as Tyrima with proven MAOI activity in
the CNS and a good safety and tolerability profile would be a valuable
option for the many patients whose depression is refractory to treatment
with currently prescribed antidepressant drugs."



CeNeRx has worldwide rights to develop and commercialize Tyrima. This
compound, which could be the first RIMA antidepressant available in the
U.S. market, has patent protection beyond 2027.



About CeNeRx BioPharma



CeNeRx is a privately held clinical stage biopharmaceutical company
developing and commercializing innovative treatments for diseases of the
central nervous system. CeNeRx's most advanced compound, a reversible
inhibitor of monoamine oxidase, or RIMA, has entered Phase II development
for the treatment of major depressive disorder. RIMAs may have efficacy
advantages over current agents for depression and are expected to have a
good safety profile. The company is also developing its pipeline of
selective cannabinoid compounds that have recently completed successful
preclinical proof-of-concept studies for the treatment of pain, glaucoma
and spasticity. More information about CeNeRx BioPharma can be found at
cenerx.


CeNeRx BioPharma, Inc.

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